Evaluating surgical outcomes for patients with malocclusion using a Surgery First approach and aligners
Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners
This study is testing whether a Surgery First approach using braces or clear aligners can improve the quality of life and treatment results for patients with a specific type of jaw misalignment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 17 Years to 35 Years |
| Sex | All |
| Sponsor | Rio de Janeiro State University Academic / other |
| Locations | 1 site (Rio de Janeiro) |
| Trial ID | NCT05822271 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to compare the treatment outcomes and quality of life for skeletal Class III patients who undergo a Surgery First approach using either conventional fixed appliances or aligners. The study will collect data through validated questionnaires, including the Orthognathic Quality of Life Questionnaire and the Oral Health Impact Profile, to assess the impact of the treatment on patients' lives. By analyzing these outcomes, the study seeks to determine the effectiveness of the Surgery First approach in improving both aesthetic and functional results for patients with specific skeletal malocclusions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with skeletal malocclusion requiring bimaxillary surgery and specific angular measurements indicating a need for surgical intervention.
Not a fit: Patients with previous orthodontic treatment, craniofacial anomalies, or other specific exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with skeletal Class III malocclusion, potentially improving their quality of life.
How similar studies have performed: While the Surgery First approach is gaining attention, this specific comparison with aligners is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults; * Skeletal malocclusion; * ANB Angle zero or negative; * Witts negative; * Etiology: mandibular excess, a maxillary deficiency, or a combination of both; * Indication for bimaxillary surgery; Exclusion Criteria: * Previous orthodontic treatment; * Craniofacial anomaly or previous fracture of the facial bones; * Total edentulism; * Deep curve of Spee; * Vertical asymmetry; * Any medication use that contraindicates surgical treatment.
Where this trial is running
Rio de Janeiro
- Rio de Janeiro State University — Rio de Janeiro, Brazil (Recruiting)
Study contacts
- Study coordinator: Arthur Cunha, MSc
- Email: cunhas.arthur@gmail.com
- Phone: 55-21-967637007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.